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CTRI Number  CTRI/2023/08/056384 [Registered on: 10/08/2023] Trial Registered Prospectively
Last Modified On: 02/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To check the effect of bhagottar gutika and abhyanga in post covid respiratory distress  
Scientific Title of Study   Clinical Study To Evaluate The Efficacy Of Bhagottar Gutika And Abhyanga In The Management Of Post COVID Respiratory Distress 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ajit Kumar Pandey 
Designation  MD Scholar 
Affiliation  Pt Khushilal Sharma Government Autonomous Ayurveda Collage And Institute Bhopal 
Address  Department Of Kayachikitsa ,Pt Khushilal Sharma Government Autonomous Ayurveda Collage And Institute Bhopal

Bhopal
MADHYA PRADESH
462003
India 
Phone  9522746358  
Fax    
Email  ajitp8312@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek sharma 
Designation  Assistant Professor 
Affiliation  Pt Khushilal Sharma Government Autonomous Ayurveda Collage And Institute Bhopal 
Address  Department Of Kayachikitsa ,Pt Khushilal Sharma Government Autonomous Ayurveda Collage And Institute Bhopal

Bhopal
MADHYA PRADESH
462003
India 
Phone  8770672790  
Fax    
Email  drvivek.sharma13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ajit Kumar Pandey 
Designation  MD SCHOLAR 
Affiliation  Pt Khushilal Sharma Government Autonomous Ayurveda Collage And Institute Bhopal 
Address  department of kayachikitsa Pt Khushilal Sharma Government Autonomous Ayurveda Collage And Institute Bhopal

Bhopal
MADHYA PRADESH
462003
India 
Phone  9522746358  
Fax    
Email  ajitp8312@gmail.com  
 
Source of Monetary or Material Support  
Pt Khushilal Sharma Government Autonomous Ayurveda Collage And Institute Bhopal 
 
Primary Sponsor  
Name  Ajit kumar pandey 
Address  department of kayackitsa Pt Khushilal Sharma Government Autonomous Ayurveda Collage And Institute Bhopal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ajit kumar pandey  Pt Khushilal Sharma Government Autonomous Ayurveda Collage And Institute Bhopal  Department of Kayachikitsa, Pt. Khushilal Sharma Government Autonomous Ayurveda College And Institute, Bhopal
Bhopal
MADHYA PRADESH 		 9522746358

ajitp8312@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Pt. Khushilal sharma govt. ayurveda institute, Bhopal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:U071||COVID 19 virus identified. Ayurveda Condition: SVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -
2Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: sahastrayogam taila yoga prakaran/227, Procedure details: abhyanga with amrutadi taila for 45 minutes for 15 days)
(1) Medicine Name: Bhagottar Gutika, Reference: Bhaishajya kalpana 15/127-129, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: qid, Duration: 30 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  58.00 Year(s)
Gender  Both 
Details  1 Age between 18 to 58 years irrespective of sex.
2 Previously confirmed cases of SARS Cov-2 Rt-PCR patients.
3 Post covid Patients presented with symptoms such as SOB, fatigue and insomnia. At least two symptoms must be
present out of which one must be SOB.
4 FEV1 greater than 80% of the predicted value.
5 Patients willing to give written consent for participation in the study. 
 
ExclusionCriteria 
Details  1 Patients having major systemic illness, renal, hepatic and Autoimmune diseases.
2 Patients who are immunocompromised such as chronic DM and HIV etc.
3 Pregnant and lactating mothers. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
It is expected that at the end of study we would be able to demonstrate the efficacy of BhagottarGutika & Abhyanga with
Amrutaditailam in the management of PCRD. 		 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
this study will helpful in treating respiratory distress patient  15th 30th & 45th day of study 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
 BhagottarGutika a herbomineral preparation  and Abhyanga with
Amrutadi tailam will be done the management of Post covid respiratory distress .
 
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